StarMed clinical evidence

Published studies on the StarMed range of CPAP and NIV respiratory hoods. For more information on the full StarMed range, including information sheets, videos and enquiries, please visit https://www.intersurgical.com/info/starmed

Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial.

Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. JAMA. 2016 Jun 14;315(22):2435-41

Single-centre randomised trial of 83 patients to determine whether NIV through helmet improves intubation rate among patients with ARDS. Primary outcome was proportion of patients who needed ETI, secondary outcomes included 28-day invasive ventilator-free days, ICU length of stay, and 90-day mortality. Authors conclude helmet NIV treatment resulted in a significant reduction of intubation rates as well as statistically significant reduction in 90-day mortality.

Link to abstract.

New versus Conventional Helmet for Delivering Noninvasive Ventilation: A Physiologic, Crossover Randomized Study in Critically Ill Patients.

Olivieri C, Longhini F, Cena T, Cammarota G, Vaschetto R, Messina A, Berni P, Magnani C, Della Corte F, Navalesi P. Anesthesiology. 2016 Jan;124(1):101-8

This study set out to assess the efficacy and safety of the new helmet (NH) in comparison to the standard helmet (SH) for the prevention of post-extubation respiratory failure (PERF). Both devices were also compared with the endotracheal tube (ETT) in place before extubation. Each of the 14 patients underwent three 30 minutes trials in pressure support ventilation, starting with ETT and after extubation, with a SH (Castar R, Intersurgical) and NH in a random order. Several parameters were evaluated including comfort, triggering delays, rates of pressurization, respiratory drive and frequency, arterial blood gases (ABGs) and rate of asynchrony. Findings have shown that the use of NH improved comfort, inspiratory trigger delay, pressurization and patient’s inspiratory time. On the other hand, respiratory drive and frequency, ABGs and rate of asynchrony were comparable between the two devices. Moreover, ETT outperformed both devices in all the parameters, apart from respiratory rate and asynchronies. Therefore, the NH provided a superior comfort and better patient-ventilator interaction in comparison to the SH.

Link to abstract.

Continuous Positive Airway Pressure for Treatment of Postoperative Hypoxemia. A Randomized Controlled Trial

Squadrone V, Coha M, Cerutti E, Schellino MM, Biolino P, Occella P, Belloni G, Vilianis G, Fiore G, Cavallo F, Ranieri VM. JAMA. 2005 Feb 2;293(5):589-95

Randomised, controlled, unblinded study on 209 patients randomyl assigned to receive oxygen or oxygen plus CPAP via helmet. Primary end point was incidence of endotracheal intubation. Authors conclude that CPAP via helmet 'may decrease the incidence of endotracheal intubation' in this scenario.

Link to abstract.

New treatment of acute hypoxemic respiratory failure: Noninvasive pressure support ventilation delivered by helmet - A pilot controlled trial

Antonelli M, Conti G, Pelosi P, Gregoretti C, Pennisi MA, Costa R, Severgnini P, Chiaranda M, Proietti R. Crit Care Med. 2002 Mar;30(3):602-8

Prospective clinical pilot investigation on 33 patients treated with noninvasive pressure support ventilation (NPSV) delivered by helmet. Each patient was matched with two controls with ARF treated with NPSV via a facial mask. Primary end points were improvement of gas exchange, need for endotracheal intubation and the complications related to NPSV. Both groups improved oxygenation after NPSV, less patients failed NPSV and were intubated in the helmet group and less complications occured, while longer continuous application of the tecnique was possible. Authors concluded that NPSV by helmet successfully treated hypoxemic ARF, with better tolerance and fewer complications than facial mask NPSV.

Link to abstract.